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Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608344
Recruitment Status : Completed
First Posted : October 29, 2020
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Rheumatoid Arthritis
Interventions Drug: Atorvastatin
Drug: Pravastatin
Drug: Rosuvastatin
Drug: Filgotinib
Enrollment 27
Recruitment Details Participants were enrolled at a study site in the United States. The first participant was screened on 04 November 2020. The last study visit occurred on 13 January 2021.
Pre-assignment Details 55 participants were screened.
Arm/Group Title Sequence AB Sequence BA
Hide Arm/Group Description Participants received a single oral dose of atorvastatin (ATV) 40 mg tablet on Day 1, followed by a washout period of 1 day, and then a single oral dose of pravastatin (PRA) 40 mg + rosuvastatin (ROS) 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 were separated by a washout period of 3 days. Participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants received single oral dose of ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 were separated by a washout period of 6 days.
Period Title: Period 1 (AB: 3 Days, BA: 11 Days)
Started 14 13
Completed 13 12
Not Completed 1 1
Reason Not Completed
Adverse Event             0             1
Investigator's Discretion             1             0
Period Title: Period 2 (AB: 11 Days, BA: 3 Days)
Started 13 12
Completed 13 12
Not Completed 0 0
Arm/Group Title Sequence AB Sequence BA Total
Hide Arm/Group Description Participants received a single oral dose of ATV 40 mg tablet on Day 1, followed by a washout period of 1 day, and then a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 were separated by a washout period of 3 days. Participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants received single oral dose of ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 were separated by a washout period of 6 days. Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
The Safety Analysis Set included all randomized participants who received at least 1 dose of any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
31  (7.2) 29  (7.6) 30  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female 14 12 26
Male 0 1 1
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Hispanic or Latino 0 1 1
Not Hispanic or Latino 14 12 26
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
American Indian or Alaska Native 0 0 0
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 3 2 5
White 10 9 19
More than one race 0 0 0
Unknown or Not Reported 1 1 2
1.Primary Outcome
Title Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
Hide Description AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set (all randomized participants who received at least 1 dose of study drug and had at least 1 non-missing PK concentration datum reported by PK laboratory for each respective analyte) with available data were analyzed.
Arm/Group Title Atorvastatin Pravastatin + Rosuvastatin Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Hide Arm/Group Description:
Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
Overall Number of Participants Analyzed 25 25 26 26
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
ATV Number Analyzed 25 participants 0 participants 26 participants 0 participants
78.8  (39.10) 70.2  (27.08)
PRA Number Analyzed 0 participants 25 participants 0 participants 26 participants
199.5  (115.64) 232.5  (137.76)
ROS Number Analyzed 0 participants 25 participants 0 participants 26 participants
62.6  (29.03) 89.3  (34.63)
2.Primary Outcome
Title PK Parameter: AUCinf of ATV, PRA, and ROS
Hide Description AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time Frame AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Atorvastatin Pravastatin + Rosuvastatin Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Hide Arm/Group Description:
Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
Overall Number of Participants Analyzed 25 25 26 26
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
ATV Number Analyzed 25 participants 0 participants 26 participants 0 participants
80.8  (39.76) 71.8  (27.30)
PRA Number Analyzed 0 participants 25 participants 0 participants 26 participants
201.3  (116.38) 234.8  (137.43)
ROS Number Analyzed 0 participants 25 participants 0 participants 26 participants
66.0  (29.53) 92.3  (34.94)
3.Primary Outcome
Title PK Parameter: Cmax of ATV, PRA, and ROS
Hide Description Cmax is defined as the maximum observed concentration of drug.
Time Frame AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Atorvastatin Pravastatin + Rosuvastatin Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Hide Arm/Group Description:
Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
Overall Number of Participants Analyzed 25 25 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
ATV Number Analyzed 25 participants 0 participants 26 participants 0 participants
19.7  (13.50) 15.0  (7.81)
PRA Number Analyzed 0 participants 25 participants 0 participants 26 participants
84.2  (56.60) 99.2  (65.68)
ROS Number Analyzed 0 participants 25 participants 0 participants 26 participants
7.5  (4.17) 12.3  (6.00)
4.Secondary Outcome
Title Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, which did not necessarily have a causal relationship with the treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation.
Time Frame Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of that particular study drug.
Arm/Group Title Atorvastatin Pravastatin + Rosuvastatin Filgotinib Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Hide Arm/Group Description:
Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
Overall Number of Participants Analyzed 26 25 26 26 26
Measure Type: Number
Unit of Measure: percentage of participants
19.2 24.0 65.4 7.7 11.5
5.Secondary Outcome
Title Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities
Hide Description Treatment-emergent laboratory abnormalities were graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 of Adverse Events and Laboratory abnormalities. Laboratory abnormalities were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening), Grade 5 (Death). Percentage of participants with Grade 3 or higher treatment-emergent laboratory abnormalities were reported.
Time Frame Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized and received at least 1 dose of that particular study drug with available data were analyzed.
Arm/Group Title Atorvastatin Pravastatin + Rosuvastatin Filgotinib Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Hide Arm/Group Description:
Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
Overall Number of Participants Analyzed 26 25 26 24 26
Measure Type: Number
Unit of Measure: percentage of participants
0 0 3.8 0 0
Time Frame Adverse Events: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days All Cause-Mortality: Sequence AB: From randomization up to 47 days, Sequence BA: From randomization up to 50 days
Adverse Event Reporting Description

Adverse Event: All randomized participants who received at least 1 dose of that particular study drug.

All Cause-Mortality: All Randomized Analysis Set included all participants randomized into the study after screening.

 
Arm/Group Title Atorvastatin Pravastatin + Rosuvastatin Filgotinib Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Hide Arm/Group Description Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2. Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2. Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1. Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1. Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
All-Cause Mortality
Atorvastatin Pravastatin + Rosuvastatin Filgotinib Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/27 (0.00%) 
Hide Serious Adverse Events
Atorvastatin Pravastatin + Rosuvastatin Filgotinib Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/26 (0.00%)   0/26 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin Pravastatin + Rosuvastatin Filgotinib Filgotinib + Atorvastatin Filgotinib + Pravastatin + Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/26 (7.69%)   4/25 (16.00%)   13/26 (50.00%)   2/26 (7.69%)   0/26 (0.00%) 
Gastrointestinal disorders           
Nausea  1  0/26 (0.00%)  1/25 (4.00%)  3/26 (11.54%)  1/26 (3.85%)  0/26 (0.00%) 
Constipation  1  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/26 (3.85%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders           
Musculoskeletal chest pain  1  0/26 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Nervous system disorders           
Headache  1  2/26 (7.69%)  2/25 (8.00%)  8/26 (30.77%)  0/26 (0.00%)  0/26 (0.00%) 
Reproductive system and breast disorders           
Metrorrhagia  1  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/26 (0.00%)  0/26 (0.00%) 
1
Term from vocabulary, MedDRA Version 23.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04608344    
Other Study ID Numbers: GS-US-417-5937
First Submitted: October 23, 2020
First Posted: October 29, 2020
Results First Submitted: December 20, 2021
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022